Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis

Sepsis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01838525
• Other study ID #: 20130419-007
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2013
• Last updated: April 23, 2013
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Chinese PLA General Hospital
• Contact: Kun Xiao, graduate
• Phone: +86 13716608331
• Email: xiaok301[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female aged 18 years old and over;

2. Clinically suspected infection;

3. Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/µl or lower than < 4,000/µl or less than 10% of bands;

Exclusion Criteria:

1. less than 18 years old;

2. immunosuppression;

3. agranulocytosis (granulocyte counts <0.5× 109/L);

4. chronic myeloid leukemia (CML);

5. malignancy;

6. less than 24 hours of the length of ICU stay;

7. reluctant to participate in the study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Outcome	The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death	28 days	No